FDA Approval for Rapid HIV-1 Test

OraSure Technologies, Inc., has announced that it has received approval from the U.S. Food and Drug Administration ('FDA') for its OraQuick® Rapid HIV-1 Antibody Test.

OraSure can now manufacture and market the OraQuick test in the United States for the detection of HIV-1 antibodies in finger-stick whole blood samples. OraQuick is the first FDA- approved rapid, point-of-care test designed to detect antibodies to HIV-1 within approximately 20 minutes.

The FDA approval is based on clinical data submitted by OraSure indicating that the OraQuick test had sensitivity of 99.6% and specificity of 100% in the clinical studies performed with finger-stick whole blood specimens.

On June 17, 2002, OraSure announced that it had entered into an agreement with Abbott Laboratories for the co-exclusive distribution of the OraQuick test in the United States. Abbott Laboratories is the market leader for the distribution of infectious disease testing products, and is expected to focus its efforts on selling the OraQuick test to hospitals and physicians' office laboratories.

Sales from OraSure to Abbott are expected to begin in the next 30 to 60 days.

'OraQuick is an important tool to assist in the rapid detection of HIV, and our collaboration with OraSure will ensure that this innovative technology is made widely available to the health care professionals and patients who need it,' said Ed Michael, vice president, immunoassay and clinical chemistry, Abbott Laboratories.

With this FDA approval, OraQuick will be available for sale to the nearly 40,000 qualified locations in the United States certified under CLIA (Clinical Laboratory Improvement Act of 1988) to perform moderately complex diagnostic tests. An estimated 17 million HIV tests are conducted annually in the United States at these locations.